• Subjects suspected of or diagnosed with the following Stage IV/metastatic malignancies:

‣ Lung: Non-small Cell Lung Cancer (NSCLC)

⁃ Skin: Cutaneous Malignancy, excluding Uveal Melanoma

⁃ Esophageal Cancer

⁃ Cervical Cancer

⁃ Endometrial Cancer

⁃ Colon Cancer: Mismatch repair deficient (dMMR) CRC only

⁃ All solid tumors with high tumor mutation burden (TMB)

⁃ All solid tumors that are microsatellite instability high (MSI-H)

⁃ All mismatch repair deficient (dMMR) solid tumors

⁃ Liver Cancer

⁃ Any metastatic solid tumor that the clinician plans to treat with immune checkpoint inhibitor (ICI) therapy. NOTE: This can be either in the setting of a trial, compassionate use, or the use of appropriate laboratory developed tests (LDTs) that, per clinician, render the patient eligible for ICI therapy, either frontline or a later line.

• OR

• Subjects suspected of or diagnosed with the following Stage III per provider discretion or IV/metastatic malignancies:

‣ Kidney: Clear Cell Renal Cell Carcinoma (ccRCC)

⁃ Bladder: Urothelial Carcinoma (UC)

• OR

• Patients who will be receiving neoadjuvant CPI for the following resectable early-stage malignancies:

‣ Breast Cancer: Triple negative breast cancer (TNBC)

⁃ Lung: Non-small cell lung cancer (NSCLC)

∙ NOTE: Patients with suspected NSCLC who would be eligible for neoadjuvant checkpoint inhibitor (CPI) are eligible to enroll per provider discretion

⁃ Any solid tumor that the clinician plans to treat with ICI therapy

• LOCALLY ADVANCED/METASTATIC PATIENTS: Measurable disease as defined per protocol NOTE: Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible.

• NEOADJUVANT PATIENTS: Subjects must be eligible based on investigator discretion to receive approved CPI therapy.

• Subjects who are newly diagnosed or have suspected cancer must be treatment-naïve at the time of biopsy.

• Subjects who are Stage I, II, or III and have progressed to metastatic cannot have received any anti-cancer treatment for at least 2 - 4 weeks (depending upon the washout period of prior anti-cancer treatment) prior to biopsy as per the agents used.

• ECOG Performance Status (PS) 0, 1 or 2.

• Negative pregnancy test done ≤7 days prior to enrollment, for persons of childbearing potential only

• Female subjects must not be pregnant or breastfeeding and must use appropriate methods of contraception when applicable.

• Subjects must be clinically able, at investigator discretion, and willing to undergo either:

‣ additional biopsy passes during their standard of care biopsy, OR

⁃ a biopsy for research only, if applicable.

⁃ NOTE: These additional biopsies may either be collected from the primary tumor or a metastatic site amenable to biopsies per the clinician.

• Subjects with a known secondary cancer diagnosis are eligible to participate if participation does not interfere with systemic anti-cancer standard of care treatment for suspected primary diagnosis.

• Provide written informed consent